Discussions continued again around Drug Listing of Export Products. Feedback from FDA was that the regulations state products in commercial distribution must be listed. There is no distinction made between foreign or domestic products. This implies that all products manufactured in the U.S. whether for domestic or foreign distribution should be drug listed. There were many issues brought up regarding this. If a product was to be sent to multiple countries, then it would need to be listed multiple times if the product has different trade names or similar scenarios. If several different countries are to receive the product, this may exhaust the NDC numbers available for a given product. Additionally, entering the language of the product, even if it is cut and paste, may not allow file to cooperate with system since many vendors may not have software that can handle certain languages. Labels are often times printed in the country of origin, so creating an SPL with this language may not be a possibility. FDA is futher investigating this. A team member will contact FDA at the DRLS office to gain insight on this regulation.
2. Change in the SPL Validation:
FDA has informed us that there will be a change in the validation procedures for SPL. Establishment information will not be needed for IND NDCs, APIs and export only products. A Principle display panel and a market stop date will be needed for a product that is no longer manufactured. At that point, the SPL file can be updated with this information and establishment information can be removed and will not result in a product failing validation. Only establishments actively involved in the processing of a product are to be included in the SPL file. This may not be consistent with the application as some CMC may include back-up sites. Also, DEA regulated INDs must be listed and INDs sold or for commercial distribution need to be listed.
3. Drug Listing Scenarios:
There are often different scenarios that do not conform to "traditional" listing. Some of the scenarios include the following:
2 labeler codes and 1 insert/SPL/CoL
4 NDAs - 4 Labeler - 1 SPL currently
Common DUNS numbers with different company names
Do others have experience with this or have other strange scenarios?
4. Next meeting - April 15, 2009 at 1 PM Eastern Time.
Discussions continued again around Drug Listing of Export Products. Feedback from FDA was that the regulations state products in commercial distribution must be listed. There is no distinction made between foreign or domestic products. This implies that all products manufactured in the U.S. whether for domestic or foreign distribution should be drug listed. There were many issues brought up regarding this. If a product was to be sent to multiple countries, then it would need to be listed multiple times if the product has different trade names or similar scenarios. If several different countries are to receive the product, this may exhaust the NDC numbers available for a given product. Additionally, entering the language of the product, even if it is cut and paste, may not allow file to cooperate with system since many vendors may not have software that can handle certain languages. Labels are often times printed in the country of origin, so creating an SPL with this language may not be a possibility. FDA is futher investigating this. A team member will contact FDA at the DRLS office to gain insight on this regulation.
2. Change in the SPL Validation:
FDA has informed us that there will be a change in the validation procedures for SPL. Establishment information will not be needed for IND NDCs, APIs and export only products. A Principle display panel and a market stop date will be needed for a product that is no longer manufactured. At that point, the SPL file can be updated with this information and establishment information can be removed and will not result in a product failing validation. Only establishments actively involved in the processing of a product are to be included in the SPL file. This may not be consistent with the application as some CMC may include back-up sites. Also, DEA regulated INDs must be listed and INDs sold or for commercial distribution need to be listed.
3. Drug Listing Scenarios:
There are often different scenarios that do not conform to "traditional" listing. Some of the scenarios include the following:
Do others have experience with this or have other strange scenarios?
4. Next meeting - April 15, 2009 at 1 PM Eastern Time.